On Friday 19th November 2010 FDA
in US banned the painkilling substance (Dextro)Propoxyphene. (DXP) This happened
from one day to another – and this was a huge mistake.
In Sweden the first restrictions - when prescribing
DXP - was June 15th 2001 - and the process to ban took some more
years. This whole process started May 11th 2001 when I had a debate article
published in the largest tabloid in Sweden Expressen. The headline in the article
was (translated into English) “The Medical Product Agency (MPA) offers 200
lives every year. Ever year around 200 persons die due to the painkiller Distalgesic
and Paraflex comp. The article covered whole page, four columns and got lots of
attention.
UK followed the Swedish example and started
their process. We were part of the process in the European Union (EU) and we
were a part if that, our rese4rcah was presented in the parliament by the
Swedish liberal member of the EU.
As soon as I read FDA news Release http://bit.ly/2G7kmmG of Nov 19th 2010 about
the banning of the painkilling substance Propoxyphene – brandmarks Darvon and
Darvocet – I was completely convince that the people who would sue Darvon and Darvocet
manufactures namely Xanodyne and Eli Lilly - the company that “invented” DXP
would not receive any damages whatsoever.
In the report you found, among other things:
- The FDA sought market withdrawal
of Propoxyphene after receiving new clinical data showing that the drug puts
patients at risk of potentially serious or even fatal heart rhythm abnormalities.
You cannot express your thoughts in a s
mild way as above – not in science. No one will ever be able to proof that
deaths of someone loved ones would depend on a risk of potentially serious
or even fatal heart rhythm abnormalities. You cannot prove that in any
court – you need facts - I also find the following:
-
Propoxyphene causes significant
changes to the electrical activity of the heart.
We wrote the following in one of our scientific
articles: “The prevalence of Dextropropoxyphene (DXP) in autopsy
blood samples”. Foer Sci Int 1998:96:165 – 142.
-
DXP was found in blood samples 782
(7,5%) of the 23 691 blood samples during the year 1992-1996.
-
The mean blood DXP concentration was 1,62 µg/g. (The DXP level in the
blood concentration to therapeutic doses from 0,05 µg/g - 0,75 µg/g).
Of the 1 782 cases 60% were men and 40% were female.
-
A significant
higher DXP level - 2,36 µg/g - was found in the group aged younger than 50 years
compared with the cases older than 50 years of age (was 1,04 µg/g).
-
We also
reported the presence of paracetamol, alcohol and sometimes also bensodiazepines .
It is from data
like this we were able to present data that are scientific correct. In the FDA
report there was no scientific data, just some vague data.
My view is that
the FDA did everything they could to get someone to unclear and vague, to write
so that no court would get accurate data at all and thus risk plaintiffs
winning in hundreds of upcoming lawsuits.
I can well call
them that they - the FDA - chose writers who were very much on the side of
pharmaceutical companies.
Can we call it
bribery? I have no problem with it. After being in the research on drugs for
more than 25 years I know that there are a lot of unethical situations.
I suggest that
you readers continue to read the rest of my text and see how the English
Medicines Agency MHRA and independent researchers from Oxford.
The MHRA in
UK (Medicines & Healthcare product Regulatory) gave Professor Keith Hawton
(University of Oxford Centre for Suicide Research) the task of submitting assist
that would be intended as a recommendation for how authorities would act in
stopping Dextropropoxphene or not.
In the article - written by professor Hawtons group - Co-proxamol and suicide:
preventing the continuing toll of overdose deaths QJM: An International Journal of Medicine, Volume 98, Issue 3, March 2005, Pages 159–170, https://doi.org/10.1093/qjmed/hci026
Some excerpt from the article.
-
Electronic searches of PsycINFO (1872–2003), MEDLINE (1966–2003),
EMBASE (1980–2003) and CINAHL (1982–2003) were done, using search
terms for co-proxamol, coproxamol, dextropropoxyphene and distalgesic
combined with terms for overdose, self poisoning, suicide and attempted
suicide. Four hundred and two papers (402) were identified. From
these we selected 42 English language papers where the contents of the
abstract were relevant to the aims of this review. Twenty additional
relevant papers were identified from reference lists.
My comment: In the final article there
were 73 articles, and we were writer of six if the (21-26) - a real
acknowledgment that our articles are appreciated. In the FDA article, there
were none that completely referenced us - which nevertheless presented most of
the research in the field in recent years
In a forthcoming
article, I will talk about the DXP issue in law
.
PS. Because I am a party to the case, I let the
readers decide for themselves the authority they feel best - most
professionally - MHRA in UK or FDA in US